Ardena U.S.
United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
✓ Press (10)
○ EMA GMP
○ MHRA GMP
✓ HC GMP (2)
Quick Facts: Ardena U.S.
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- United States
- Website
- https://ardena.com/
- Modalities
- Oral Solid Dose, Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Ardena U.S.
Ardena U.S. is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Sterile Fill-Finish. 3 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://ardena.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Ardena U.S. FDA Inspection History
2025-11
2023-02
2022-05
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-21 |
Ardena U.S. LLC
Somerset, New Jersey
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2023-02-01 |
Ardena U.S. LLC
Somerset, New Jersey
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2022-05-25 |
Ardena Oss BV
Oss
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Hiring Activity 8 open roles Beta
From public job postings on the parent company's careers board, as of Oct 30, 2026. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
8
open roles
5
in manufacturing, quality, PD/MSAT, engineering or regulatory (62%)
Trend from Nov 29, 2026
Tracking started Oct 30, 2026. 30-day change shows after 30 days, 90-day after Jan 28, 2027.
By function
By site
Somerset, United States
4 mfg/ops · 1 QA/QC · 3 other 8
4 mfg/ops · 1 QA/QC · 3 other 8
Latest postings
QA Officer CRO/Senior QA Officer (QA Specialist Bioanalytics)
Other (finance, HR, IT, other) · Somerset, United States · posted Oct 3, 2026
Associate Director, Finance
Other (finance, HR, IT, other) · Somerset, United States · posted Aug 24, 2026
Pharmaceutical Technician I
Manufacturing & operations · Somerset, United States · posted Aug 17, 2026
Master Planner
Manufacturing & operations · Somerset, United States · posted Aug 14, 2026
3rd Shift Supervisor
Manufacturing & operations · Somerset, United States · posted Aug 10, 2026
Scientist – Quality Control (QC)
Quality (QA / QC) · Somerset, United States · posted Jun 30, 2026
Director - Bioanalytics (Business Unit Head)
Other (finance, HR, IT, other) · Somerset, United States · posted Mar 4, 2026
GMP Cleaner
Manufacturing & operations · Somerset, United States · posted Nov 4, 2025
Coverage: read from the parent company's careers board and kept only postings at this business's sites (group board filtered to the profile site (Somerset, NJ)). Roles outside those sites are left out, and some of this unit's roles may be missed.
Function groups come mainly from job titles (about 84% match a hand check), and modality words from titles only, so both are approximate.
Source:
careers.ardena.com
· Checked Oct 30, 2026 · Tracking since Oct 30, 2026
Company Signals 10 articles
Company announcements, not verified evidence. They do not change any score.
Sweden's Nanologica acquires API facility from CDMO Ardena, brings team of 45 on board - Fierce Pharma
Ardena’s US plant buy pays off as CDMO endures rough geopolitical waters - Fierce Pharma
Ardena Completes Acquisition of Advanced Drug Product - GlobeNewswire
Ardena divests Södertälje drug substance site to Nanologica - European Pharmaceutical Review
Belgian CDMO Ardena gets new private equity owners - BioPharma Dive
Ardena Expands with Key U.S. Facility Buy - Manufacturing Today
Precision Medicine in Focus: Ardena’s Strategic Growth & Innovation Under CEO Jeremie Trochu - Contract Pharma
10 CDMO Up & Comers - Genetic Engineering and Biotechnology News
Ardena Strengthens Executive Team to Drive its Next Phase of Growth - BioSpace
Ardena Names Dr. Ariane de Ganck as Chief Scientific Officer - Contract Pharma
Frequently Asked Questions About Ardena U.S.
How many FDA inspections does Ardena U.S. have on record?
CDMO Signal tracks 3 FDA inspections for Ardena U.S., sourced from the FDA inspection database. See the full inspection history above.
Has Ardena U.S. received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Ardena U.S..
Does Ardena U.S. have a CDMO Signal Score?
Not yet. Ardena U.S. is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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